Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome

The purpose of this research is to find out how a nasal spray (fluticasone furoate), sometimes given to children with obstructive sleep apnea syndrome (OSAS), works on certain cells within a child's adenoids. We hypothesize that intranasal steroids lead to an upregulation of T regulatory cells in the adenoid tissues of children with OSAS. This will result in a local reduction in inflammation and edema explaining the improvement in OSAS.

Study Overview

• Status: Completed
• Conditions: Childhood Obstructive Sleep Apnea Syndrome (OSAS)
• Intervention / Treatment: Drug: fluticasone furoate

Detailed Description

The objective was to determine the effect of intranasal corticosteroid therapy on T-regulatory cells and other inflammatory cytokines in adenoid tissues in children with obstructive sleep apnea syndrome.Children were randomized to either no treatment or treatment with fluticasone furoate nasal spray, 55 μg/nostril daily, for 2 weeks before adenotonsillectomy. Adenoid tissue was obtained at the time of the procedure.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: between 2 and 12 years
• Polysomnogram results showing AHI >5/hr irrespective of saturations
• No other significant medical problems except well controlled asthma
• No chronic medication intake except bronchodilators and leukotriene receptor antagonists
• No systemic steroids within the past month
• No intranasal steroids within the past 2 weeks

Exclusion Criteria:

• Patients with OSAS who are overweight (BMI>95th percentile for age) or who have neurological or craniofacial abnormalities as these tend to have OSAS related to these factors per se.
• Females of the specified age group who have already had their first period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No treatment
Active Comparator: Fluticasone furoate; 55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy	Drug: fluticasone furoate; treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy; Other Names: Veramyst

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of CD25 Pos/FoxP3 Positive Cells	The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25	following adenoidectomy (2 weeks)
Number of CD4 Pos/FOXP3 Positive Cells	The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25	following adenoidectomy (2 weeks)
IL-10 Staining Intensity	IL-10 staining intensity on immunohistochemical staining of adenoid tissues. Units are Integrated optical density (IOD)/100 micrometer squared.	following adenoidectomy (2 weeks)
Amount of IL-10 Secreted by Adenoid Cells After PHA Stimulation	Amount of IL-10 secreted by adenoid cells after PHA stimulation	following adenoidectomy (2 weeks)
Amount of TGF Secreted by Adenoid Cells After PHA Stimulation	Amount of TGF secreted by adenoid cells after PHA stimulation	following adenoidectomy (2 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjusted Volume of the Removed Adenoids	To adjust for different weights of the children, the volume of the adenoids, estimated by water displacement in the operating room in mL, was divided by the respective weights (kg) of the patients and multiplied by 100.	following adenoidectomy (2 weeks)

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Fuad M Baroody, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: January 3, 2008
• First Submitted That Met QC Criteria: January 26, 2008
• First Posted (Estimate): January 28, 2008

Study Record Updates

• Last Update Posted (Estimate): May 4, 2015
• Last Update Submitted That Met QC Criteria: April 29, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone; Xhance
• Other Study ID Numbers: 15868B